Addressing Clinical Relevance in Medical Papers (12)

Precision Evidence

Addressing Clinical Relevance in Medical Papers

Clinical trials and research should always aim to provide information that is meaningful and relevant for patients.

In the last episode, we looked at how many - or rather - how few researchers mentioned and argued for what they would see as clinically relevant outcomes when setting up a study and listing it on clinicaltrials.gov

In this episode, we go deeper to look at examples and why this is so important to improve the usefulness of the research

We want to make it mandatory to state the researchers' clinical relevance levels ahead of the trial, mentioning what they will consider clinically relevant when they pre-register their research on the clinicaltrials.gov website or similar websites. They then need to compare their findings in both the paper and abstract when publishing data from the study. #clinicalrelevance

LINKS:

Once-Weekly Semaglutide in Adults with Overweight or Obesity Paper https://www.nejm.org/doi/full/10.1056/NEJMoa2032183

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/study/NCT03548935

10-Year Update on Study Results Submitted to ClinicalTrials.gov

https://www.nejm.org/doi/full/10.1056/NEJMsr1907644

FDA and NIH let clinical trial sponsors keep results secret and break the law https://www.sciencemag.org/news/2020/01/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-law

Compliance with the legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(19)33220-9.pdf

Our specific page on our website about requesting clinical relevance statement and evaluation https://www.precision-evidence.com/p/clinical-relevance/

Overview of clinical trials registers like clinicaltrials.gov: https://sites.google.com/a/york.ac.uk/yhectrialsregisters/home/clinicaltrials

Precision Evidence episode 11: “Clinical relevance - Looking at Recent Papers” https://www.precision-evidence.com/11

NOTES:

• Why is stating levels for clinical relevance important to make before a clinical trial starts?
• How should authors of clinical research papers refer and compare to clinical relevance statements?
• Looking at a specific study
• Importance of also looking at how the study is done
• In/exclusion criteria
• Compliance with listing on clinicaltrials.gov
• Compliance with publishing results on clinicaltrials.gov
• Challenges to make a comprehensive review and analysis of a medical paper to make sure the information is both trustworthy and clinically relevant

GET THE ABSTRACT SCREENING TOOL

It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool to use when reading an abstract from a clinical research paper.

Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com

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Hosts:

Dr. Kim Kristiansen, M.D: @KKristiansenMD & https://www.linkedin.com/in/kim-kristiansen

JG Staal: @HealthyEvidence

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